Catalog Number

-

Brand Name

Lipogems Process Device

Version/Model Number

LGD 60

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K142682,K171135,K142682,K171135,K142682,K171135

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

f667da52-babb-472b-97f0-8f96ce9121d7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

18058773562484

Quantity per Package

6

Contains DI Package

08058773562487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box